Valproate Pregnancy Prevention Programme: temporary guidance issued by MHRA during COVID-19 pandemic

07 May 2020

The MHRA has issued temporary guidance for the management of the Valproate Pregnancy Prevention Programme during coronavirus (COVID-19)

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued temporary guidance for management of the Valproate Pregnancy Prevention Programme (PPP) during the coronavirus (COVID-19) pandemic to assist specialists in initiating valproate in female patients, undertaking annual reviews, and pregnancy testing procedures during the COVID-19 pandemic.

Although the temporary guidance is intended for specialists, pharmacy teams should read the new guidance and be aware of the temporary processes in place due to the pandemic, as well as understand and implement the full MHRA guidance; this includes guidance on dispensing prescriptions for valproate medicines for females of childbearing age.

  • Valproate is known to be highly teratogenic at all strengths.
  • Exposure during pregnancy carries a 10% risk of children being born with congenital malformations and 30-40% risk of neurodevelopmental delays.
  • Prescribers must ensure females of child-bearing age satisfy the requirements of the Pregnancy Prevention Programme (PPP).

 

Read the full MHRA guidance here (includes the temporary advice for management of valproate during the coronavirus outbreak: https://www.gov.uk/guidance/valproate-use-by-women-and-girls#toolkit

NPA support

The following valproate resources are available from the NPA to support patient safety:

For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email pharmacyservices@npa.co.uk.

 

Produced by the NPA Pharmacy Services team May 2020.